
Compliance Expert
2 days ago
As a key player in product development, you will leverage your expertise in regulatory submissions to support product lifecycle management and commercialization.
- Key Responsibilities:
- Prepare, review, and submit regulatory filings including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensure compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
- Collaborate with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
- Core Skills:
- Develop and maintain regulatory strategies to support new product development and lifecycle management.
- Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
- Team Collaboration:
- Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Assist in responding to regulatory queries, deficiency letters, and inspection findings.
- Documentation Management:
- Manage regulatory documentation archives and maintain compliance records for audits and inspections.
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